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Volumn 24, Issue 12, 2015, Pages 1259-1270

Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone

Author keywords

benefit risk assessment; cardiovascular diseases; NNH; pharmacoepidemiology; pioglitazone; rosiglitazone; safety based drug withdrawals

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; PIOGLITAZONE; ROSIGLITAZONE;

EID: 84977634385     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3874     Document Type: Article
Times cited : (20)

References (63)
  • 1
    • 22144474788 scopus 로고    scopus 로고
    • Adverse drug event surveillance and drug withdrawals in the United States, 1969–2002: the importance of reporting suspected reactions
    • Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969–2002: the importance of reporting suspected reactions. Arch Intern Med 2005 Jun 27; 165(12): 1363–9.
    • (2005) Arch Intern Med , vol.165 , Issue.12 , pp. 1363-1369
    • Wysowski, D.K.1    Swartz, L.2
  • 2
    • 32244432294 scopus 로고    scopus 로고
    • An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets
    • Clarke A, Deeks JJ, Shakir SA. An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets. Drug Saf 2006; 29(2): 175–81.
    • (2006) Drug Saf , vol.29 , Issue.2 , pp. 175-181
    • Clarke, A.1    Deeks, J.J.2    Shakir, S.A.3
  • 4
    • 84892860718 scopus 로고    scopus 로고
    • An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making
    • McNaughton R, Huet G, Shakir S. An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making. BMJ Open 2014 Jan 15; 4(1): e004221.
    • (2014) BMJ Open , vol.4 , Issue.1
    • McNaughton, R.1    Huet, G.2    Shakir, S.3
  • 5
    • 57049133083 scopus 로고    scopus 로고
    • Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects
    • Vandenbroucke JP, Psaty BM. Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects. JAMA 2008 Nov 26; 300(20): 2417–9.
    • (2008) JAMA , vol.300 , Issue.20 , pp. 2417-2419
    • Vandenbroucke, J.P.1    Psaty, B.M.2
  • 6
    • 84883202910 scopus 로고    scopus 로고
    • The future of population-based postmarket drug risk assessment: a regulator's perspective
    • Hammad TA, Neyarapally GA, Iyasu S, Staffa JA, Dal PG. The future of population-based postmarket drug risk assessment: a regulator's perspective. Clin Pharmacol Ther 2013 Sep; 94(3): 349–58.
    • (2013) Clin Pharmacol Ther , vol.94 , Issue.3 , pp. 349-358
    • Hammad, T.A.1    Neyarapally, G.A.2    Iyasu, S.3    Staffa, J.A.4    Dal, P.G.5
  • 8
  • 9
    • 84870508803 scopus 로고    scopus 로고
    • A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer
    • Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract 2012 Nov; 98(2): 271–84.
    • (2012) Diabetes Res Clin Pract , vol.98 , Issue.2 , pp. 271-284
    • Alves, C.1    Batel-Marques, F.2    Macedo, A.F.3
  • 10
    • 84952861671 scopus 로고    scopus 로고
    • A case study using the PrOACT-URL and BRAT frameworks for structured benefit risk assessment
    • [Epub ahead of print]
    • Nixon R, Dierig C, Mt-Isa S, et al. A case study using the PrOACT-URL and BRAT frameworks for structured benefit risk assessment. Biom J 2015 Jan 26. doi:10.1002/bimj.201300248. [Epub ahead of print].
    • (2015) Biom J
    • Nixon, R.1    Dierig, C.2    Mt-Isa, S.3
  • 13
    • 79959542542 scopus 로고    scopus 로고
    • Benefit-risk assessment: to quantify or not to quantify, that is the question
    • Yuan Z, Levitan B, Berlin JA. Benefit-risk assessment: to quantify or not to quantify, that is the question. Pharmacoepidemiol Drug Saf 2011 Jun; 20(6): 653–6.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , Issue.6 , pp. 653-656
    • Yuan, Z.1    Levitan, B.2    Berlin, J.A.3
  • 14
    • 77955391449 scopus 로고    scopus 로고
    • A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy—report of the ISPOR risk-benefit management working group
    • Guo JJ, Pandey S, Doyle J, Bian B, Lis Y, Raisch DW. A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy—report of the ISPOR risk-benefit management working group. Value Health 2010 Aug; 13(5): 657–66.
    • (2010) Value Health , vol.13 , Issue.5 , pp. 657-666
    • Guo, J.J.1    Pandey, S.2    Doyle, J.3    Bian, B.4    Lis, Y.5    Raisch, D.W.6
  • 15
    • 84889574642 scopus 로고    scopus 로고
    • The risks of risk aversion in drug regulation
    • Eichler HG, Bloechl-Daum B, Brasseur D, et al. The risks of risk aversion in drug regulation. Nat Rev Drug Discov 2013 Dec; 12(12): 907–16.
    • (2013) Nat Rev Drug Discov , vol.12 , Issue.12 , pp. 907-916
    • Eichler, H.G.1    Bloechl-Daum, B.2    Brasseur, D.3
  • 16
    • 84952761319 scopus 로고    scopus 로고
    • 2011. Available from, accessed April 02, 2015
    • European Medicines Agency. Benefit–risk methodology project. Work package 3 report: field tests. 2011. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/09/WC500112088.pdf, accessed April 02, 2015.
    • Benefit–risk methodology project. Work package 3 report: field tests
  • 17
    • 84977653550 scopus 로고    scopus 로고
    • 2013. Available from, accessed April 02, 2015
    • Protect Consortium. Review of methodologies for benefit and risk assessment of medication. 2013. Available from: http://www.imi-protect.eu/documents/ShahruletalReviewofmethodologiesforbenefitandriskassessmentofmedicationMay2013.pdf, accessed April 02, 2015.
    • Review of methodologies for benefit and risk assessment of medication
  • 18
    • 84903794459 scopus 로고    scopus 로고
    • Balancing benefit and risk of medicines: a systematic review and classification of available methodologies
    • Mt-Isa S, Hallgreen CE, Wang N, et al. Balancing benefit and risk of medicines: a systematic review and classification of available methodologies. Pharmacoepidemiol Drug Saf 2014 Jul; 23(7): 667–78.
    • (2014) Pharmacoepidemiol Drug Saf , vol.23 , Issue.7 , pp. 667-678
    • Mt-Isa, S.1    Hallgreen, C.E.2    Wang, N.3
  • 19
    • 0023887476 scopus 로고
    • An assessment of clinically useful measures of the consequences of treatment
    • Laupacis A, Sackett D, Roberts R. An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988; 318: 1728–33.
    • (1988) N Engl J Med , vol.318 , pp. 1728-1733
    • Laupacis, A.1    Sackett, D.2    Roberts, R.3
  • 20
    • 0028908929 scopus 로고
    • The number needed to treat: a clinically useful measure of treatment effect
    • Cook D, Sackett D. The number needed to treat: a clinically useful measure of treatment effect. BMJ 1995; 310: 452–4.
    • (1995) BMJ , vol.310 , pp. 452-454
    • Cook, D.1    Sackett, D.2
  • 21
    • 84876475573 scopus 로고    scopus 로고
    • When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed
    • Citrome L, Ketter TA. When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed. Int J Clin Pract May 2013; 67(5): 407–411.
    • (2013) Int J Clin Pract , vol.67 , Issue.5 , pp. 407-411
    • Citrome, L.1    Ketter, T.A.2
  • 25
    • 84897110799 scopus 로고    scopus 로고
    • July 13 and 14, 2010. Available from, accessed April 01, 2015
    • US FDA Briefing Document. Advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) tablet. July 13 and 14, 2010. Available from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218493.pdf, accessed April 01, 2015.
    • Advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) tablet
  • 27
    • 79953203593 scopus 로고    scopus 로고
    • Comparative cardiovascular effects of thiazolidinediones: systematic review and meta-analysis of observational studies
    • Loke YK, Kwok CS, Singh S. Comparative cardiovascular effects of thiazolidinediones: systematic review and meta-analysis of observational studies. BMJ 2011 Mar 17; 342: d1309.
    • (2011) BMJ , vol.342 , pp. d1309
    • Loke, Y.K.1    Kwok, C.S.2    Singh, S.3
  • 28
    • 0022992740 scopus 로고
    • Meta-analysis in clinical trials
    • DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986 Sep; 7(3): 177–88.
    • (1986) Control Clin Trials , vol.7 , Issue.3 , pp. 177-188
    • DerSimonian, R.1    Laird, N.2
  • 29
    • 0041876133 scopus 로고    scopus 로고
    • Measuring inconsistency in meta-analysis
    • Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analysis. BMJ 2003 Sep 6; 327(7414): 557–60.
    • (2003) BMJ , vol.327 , Issue.7414 , pp. 557-560
    • Higgins, J.P.1    Thompson, S.G.2    Deeks, J.J.3    Altman, D.G.4
  • 31
    • 84880323061 scopus 로고    scopus 로고
    • Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes
    • Wing RR, Bolin P, Brancati FL, et al
    • Look AHEAD Research Group, Wing RR, Bolin P, Brancati FLet al. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med 2013 Jul 11; 369(2): 145–54.
    • (2013) N Engl J Med , vol.369 , Issue.2 , pp. 145-154
  • 32
    • 84977620679 scopus 로고    scopus 로고
    • Available from, accessed April 23, 2015
    • European Medicines Agency. Assessment report for AVANDIA (procedure no. EMA/H/C/000268/A20/0075). 2010. Available from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000268/WC500100757.pdf, accessed April 23, 2015.
    • Assessment report for AVANDIA (procedure no. EMA/H/C/000268/A20/0075). 2010
  • 33
    • 34250212715 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
    • Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007 Jun 14; 356(24): 2457–71.
    • (2007) N Engl J Med , vol.356 , Issue.24 , pp. 2457-2471
    • Nissen, S.E.1    Wolski, K.2
  • 34
    • 34250178250 scopus 로고    scopus 로고
    • Rosiglitazone and cardiovascular risk
    • Psaty BM, Furberg CD. Rosiglitazone and cardiovascular risk. N Engl J Med 2007 Jun 14; 356(24): 2522–4.
    • (2007) N Engl J Med , vol.356 , Issue.24 , pp. 2522-2524
    • Psaty, B.M.1    Furberg, C.D.2
  • 35
    • 34250172079 scopus 로고    scopus 로고
    • Cardiovascular safety of rosiglitazone
    • Krall RL. Cardiovascular safety of rosiglitazone. Lancet 2007 Jun 16; 369(9578): 1995–6.
    • (2007) Lancet , vol.369 , Issue.9578 , pp. 1995-1996
    • Krall, R.L.1
  • 36
    • 34250826679 scopus 로고    scopus 로고
    • Rosiglitazone and cardiotoxicity—weighing the evidence
    • Nathan DM. Rosiglitazone and cardiotoxicity—weighing the evidence. N Engl J Med 2007 Jul 5; 357(1): 64–6.
    • (2007) N Engl J Med , vol.357 , Issue.1 , pp. 64-66
    • Nathan, D.M.1
  • 37
    • 34347387519 scopus 로고    scopus 로고
    • Rosiglitazone—continued uncertainty about safety
    • Drazen JM, Morrissey S, Curfman GD. Rosiglitazone—continued uncertainty about safety. N Engl J Med 2007 Jul 5; 357(1): 63–4.
    • (2007) N Engl J Med , vol.357 , Issue.1 , pp. 63-64
    • Drazen, J.M.1    Morrissey, S.2    Curfman, G.D.3
  • 38
    • 34648843711 scopus 로고    scopus 로고
    • Thiazolidinediones, deadly sins, surrogates, and elephants
    • Cleland JG, Atkin SL. Thiazolidinediones, deadly sins, surrogates, and elephants. Lancet 2007 Sep 29; 370(9593): 1103–4.
    • (2007) Lancet , vol.370 , Issue.9593 , pp. 1103-1104
    • Cleland, J.G.1    Atkin, S.L.2
  • 39
    • 34648835197 scopus 로고    scopus 로고
    • 9593)1101
    • [No authors listed]. Ensuring drug safety: lessons from the thiazolidinediones. Lancet. 2007 Sep 29;370(9593):1101.
    • (2007) Lancet , vol.370
  • 40
    • 34548438086 scopus 로고    scopus 로고
    • The Avandia debate
    • Bloomgarden ZT. The Avandia debate. Diabetes Care 2007 Sep; 30(9): 2401–8.
    • (2007) Diabetes Care , vol.30 , Issue.9 , pp. 2401-2408
    • Bloomgarden, Z.T.1
  • 41
    • 61449242756 scopus 로고    scopus 로고
    • The rosigliazone meta-analysis: lessons for the future
    • Shuster JJ, Schatz DA. The rosigliazone meta-analysis: lessons for the future. Diabetes Care 2008 Mar; 31(3): e10.
    • (2008) Diabetes Care , vol.31 , Issue.3
    • Shuster, J.J.1    Schatz, D.A.2
  • 43
    • 80052179489 scopus 로고    scopus 로고
    • Assessing the benefit: risk ratio of a drug—randomized and naturalistic evidence
    • Curtin F, Schulz P. Assessing the benefit: risk ratio of a drug—randomized and naturalistic evidence. Dialogues Clin Neurosci 2011; 13(2): 183–90.
    • (2011) Dialogues Clin Neurosci , vol.13 , Issue.2 , pp. 183-190
    • Curtin, F.1    Schulz, P.2
  • 44
    • 73549118356 scopus 로고    scopus 로고
    • Relative vs. absolute measures of benefit and risk: what's the difference?
    • Citrome L. Relative vs. absolute measures of benefit and risk: what's the difference? Acta Psychiatr Scand 2010 Feb; 121(2): 94–102.
    • (2010) Acta Psychiatr Scand , vol.121 , Issue.2 , pp. 94-102
    • Citrome, L.1
  • 45
    • 66949116333 scopus 로고    scopus 로고
    • Communicating benefit and risk
    • Baglin T. Communicating benefit and risk. Br J Haematol 2009 Jun; 146(1): 31–3.
    • (2009) Br J Haematol , vol.146 , Issue.1 , pp. 31-33
    • Baglin, T.1
  • 46
    • 0037368634 scopus 로고    scopus 로고
    • Numbers needed to treat derived from meta-analysis: a word of caution
    • Marx A, Bucher HC. Numbers needed to treat derived from meta-analysis: a word of caution. Evid Based Med 2003; 8: 36–37.
    • (2003) Evid Based Med , vol.8 , pp. 36-37
    • Marx, A.1    Bucher, H.C.2
  • 47
    • 77955285732 scopus 로고    scopus 로고
    • Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality
    • Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med 2010 Jul 26; 170(14): 1191–1201.
    • (2010) Arch Intern Med , vol.170 , Issue.14 , pp. 1191-1201
    • Nissen, S.E.1    Wolski, K.2
  • 48
    • 0036204073 scopus 로고    scopus 로고
    • Commentary: relative treatment effects are consistent across the spectrum of underlying risks…usually
    • McAlister FA. Commentary: relative treatment effects are consistent across the spectrum of underlying risks…usually. Int J Epidemiol 2002; 31: 76–7.
    • (2002) Int J Epidemiol , vol.31 , pp. 76-77
    • McAlister, F.A.1
  • 49
    • 67149146438 scopus 로고    scopus 로고
    • Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial
    • Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009 Jun 20; 373(9681): 2125–35.
    • (2009) Lancet , vol.373 , Issue.9681 , pp. 2125-2135
    • Home, P.D.1    Pocock, S.J.2    Beck-Nielsen, H.3
  • 50
    • 84856992244 scopus 로고    scopus 로고
    • Rosiglitazone, myocardial ischemic risk, and recent regulatory actions
    • Bourg CA, Phillips BB. Rosiglitazone, myocardial ischemic risk, and recent regulatory actions. Ann Pharmacother 2012 Feb; 46(2): 282–9.
    • (2012) Ann Pharmacother , vol.46 , Issue.2 , pp. 282-289
    • Bourg, C.A.1    Phillips, B.B.2
  • 51
    • 84901677313 scopus 로고    scopus 로고
    • Drug-safety alerts issued by regulatory authorities: usefulness of meta-analysis in predicting risks earlier
    • Alves C, Marques FB, Macedo AF. Drug-safety alerts issued by regulatory authorities: usefulness of meta-analysis in predicting risks earlier. Eur J Clin Pharmacol 2014 Jun; 70(6): 745–56.
    • (2014) Eur J Clin Pharmacol , vol.70 , Issue.6 , pp. 745-756
    • Alves, C.1    Marques, F.B.2    Macedo, A.F.3
  • 52
    • 84888698754 scopus 로고    scopus 로고
    • The use of meta-analysis in pharmacoepidemiology
    • In, 5th edn, Strom B, Kimmel S, Hennessy S, (eds.) edn., John Wiley & Sons, Chichester, England
    • Berlin J, Soledad Cepeda M, Kim C. The use of meta-analysis in pharmacoepidemiology. In Pharmacoepidemiology (5th edn), Strom B, Kimmel S, Hennessy S (eds.) edn. John Wiley & Sons: Chichester, England, 2012; 723–756.
    • (2012) Pharmacoepidemiology , pp. 723-756
    • Berlin, J.1    Soledad Cepeda, M.2    Kim, C.3
  • 53
    • 33644763919 scopus 로고    scopus 로고
    • What is the best evidence for determining harms of medical treatment?
    • Vandenbroucke JP. What is the best evidence for determining harms of medical treatment? CMAJ 2006 Feb 28; 174(5): 645–6.
    • (2006) CMAJ , vol.174 , Issue.5 , pp. 645-646
    • Vandenbroucke, J.P.1
  • 54
    • 2442649987 scopus 로고    scopus 로고
    • When are observational studies as credible as randomised trials?
    • Vandenbroucke JP. When are observational studies as credible as randomised trials? Lancet 2004 May 22; 363(9422): 1728–31.
    • (2004) Lancet , vol.363 , Issue.9422 , pp. 1728-1731
    • Vandenbroucke, J.P.1
  • 55
    • 0347949544 scopus 로고    scopus 로고
    • Assessing the quality of research
    • Glasziou P, Vandenbroucke JP, Chalmers I. Assessing the quality of research. BMJ 2004 Jan 3; 328(7430): 39–41.
    • (2004) BMJ , vol.328 , Issue.7430 , pp. 39-41
    • Glasziou, P.1    Vandenbroucke, J.P.2    Chalmers, I.3
  • 56
    • 33644752689 scopus 로고    scopus 로고
    • Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies
    • Papanikolaou PN, Christidi GD, Ioannidis JP. Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies. CMAJ 2006 Feb 28; 174(5): 635–41.
    • (2006) CMAJ , vol.174 , Issue.5 , pp. 635-641
    • Papanikolaou, P.N.1    Christidi, G.D.2    Ioannidis, J.P.3
  • 57
    • 44249104468 scopus 로고    scopus 로고
    • Evaluating drug toxicity signals: is a hierarchical classification of evidence useful or a hindrance?
    • van Staa TP, Smeeth L, Persson I, Parkinson J, Leufkens HG. Evaluating drug toxicity signals: is a hierarchical classification of evidence useful or a hindrance? Pharmacoepidemiol Drug Saf 2008 May; 17(5): 475–84.
    • (2008) Pharmacoepidemiol Drug Saf , vol.17 , Issue.5 , pp. 475-484
    • van Staa, T.P.1    Smeeth, L.2    Persson, I.3    Parkinson, J.4    Leufkens, H.G.5
  • 58
    • 0141505916 scopus 로고    scopus 로고
    • Benefit-risk analysis: a proposal using quantitative methods
    • Holden WL, Juhaeri J, Dai W. Benefit-risk analysis: a proposal using quantitative methods. Pharmacoepidemiol Drug Saf 2003 Oct-Nov; 12(7): 611–6.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , Issue.7 , pp. 611-616
    • Holden, W.L.1    Juhaeri, J.2    Dai, W.3
  • 59
    • 0347600596 scopus 로고    scopus 로고
    • Benefit-risk analysis: examples using quantitative methods
    • Holden WL, Juhaeri J, Dai W. Benefit-risk analysis: examples using quantitative methods. Pharmacoepidemiol Drug Saf 2003 Dec; 12(8): 693–7.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , Issue.8 , pp. 693-697
    • Holden, W.L.1    Juhaeri, J.2    Dai, W.3
  • 60
    • 84940253289 scopus 로고    scopus 로고
    • Benefit-risk assessment in a post-market setting: a case study integrating real-life experience into benefit-risk methodology
    • Hallgreen CE, van den Ham HA, Mt-Isa S, et al. Benefit-risk assessment in a post-market setting: a case study integrating real-life experience into benefit-risk methodology. Pharmacoepidemiol Drug Saf 2014 Sep; 23(9): 974–83.
    • (2014) Pharmacoepidemiol Drug Saf , vol.23 , Issue.9 , pp. 974-983
    • Hallgreen, C.E.1    van den Ham, H.A.2    Mt-Isa, S.3


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